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临床试验/NCT04364282
NCT04364282已完成不适用

War of Attrition: Predicting Dropout From Pediatric Weight Management

Wake Forest University Health Sciences4 个研究点 分布在 1 个国家目标入组 1,216 人开始时间: 2020年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,216
试验地点
4
主要终点
Attrition from weight management

研究概览

简要总结

Attrition from pediatric weight management programs is unacceptably high, with dropout ranging from 27-73%. This project will utilize a model that predicts dropout from treatment, increasing its power and accuracy through a multi-site observational study. This will result in a powerful tool that will be used to decrease attrition from pediatric weight management, with the potential for widespread dissemination to improve treatment outcomes.

详细描述

The obesity epidemic is one of the foremost threats to the health of children and adults in the U.S today. Multidisciplinary pediatric weight management programs have been deemed effective, with increased access to these programs strongly advocated. However, the effectiveness of these programs is limited by attrition, with dropout ranging from 27-73%, limiting health benefits to children and inefficiently utilizing already scarce resources. In addition to better understanding the drivers of attrition, being able to predict or forecast dropout holds great potential to improve adherence and outcomes, and modify treatment approaches to best serve the needs of families. Using a model that isolates variables associated with attrition from pediatric weight management to forecast participant dropout, this prospective, longitudinal observational study will collect comprehensive data on child and family-, obesity-, and treatment-related variables In Stage 1, investigators will install an attrition forecasting model, the Outcomes Forecasting System (OFS), in 3 pediatric weight management programs, and build its precision and calibration using a conceptual model of adherence. In Stage 2, we will establish external validation, installing the OFS in a fourth weight management program, and temporal validation through continued use of the OFS within the 3 original sites. The overall goal of this project is to increase the accuracy and power of an attrition prediction model through its installation in weight management programs and to demonstrate its internal, external, and temporal validity. A greater understanding of patient, family, and disease-specific factors that predict dropout from pediatric weight management can be utilized to prevent attrition. By identifying the most pertinent factors driving attrition across weight management sites, new avenues for treatment and prevention will be identified. This project will result in a valuable tool, available for dissemination across a diverse array of clinical programs to improve adherence, decrease costs, and improve outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
7 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Child is 7-18 years of age
  • Participating child has been referred to one of the participating weight management programs, and the family (child-parent dyad) has chosen to participate in said program.
  • Participating child is obese (BMI ≥95th percentile for age and sex).
  • Participating child provides assent to participation in the research study.
  • At least one parent/guardian consents to participate (and consent to child participation).
  • The parent should be the primary parent accompanying the child to treatment, and the child's primary residence must be with that parent.
  • - Both members of the parent-child dyad must speak either English or Spanish.

排除标准

  • Participating child cannot complete measures and study activities (non-verbal, significant developmental and behavioral challenges).
  • Participating child has a chronic illness that impacts weight (i.e. cancer).
  • Participating child with a genetic condition (i.e. Prader-Willi) that is associated with excessive weight.
  • One member of the parent-child dyad refuses to participate in the study or does not wish to complete 6 months of treatment.
  • One member of the parent-child dyad is unable to participate in 6 month follow-up data collection.

结局指标

主要结局

Attrition from weight management

时间窗: 6 months

Completion of treatment is defined as completing 6 months of participation in weight-management program (attending the recommended number of visits, and still considered active after 6 months)

次要结局

  • Percent of the 95th percentile BMI(6 months)
  • General and psychosocial health (Child)(6 months)
  • Stress (Child report)(6 months)
  • Body mass index (BMI) z score(6 months)
  • General and psychosocial health (Parent)(6 months)
  • Body weight(6 months)
  • Family Health Habits(6 months)
  • Family function (Parent report)(6 months)
  • Family function (Child report)(6 months)
  • Household environment (Parent report)(6 months)
  • Household environment (Child report)(6 months)
  • Health Literacy(6 months)
  • Stress (Parent report)(6 months)
  • Motivation/self-efficacy(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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